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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
510(k) Number K844173
Device Name FEMTEST
Applicant
Bionexus, Inc.
5257 N. Blvd.
P.O. Drawer 58517
Raleigh,  NC  27658
Applicant Contact CHARLES R DESMET
Correspondent
Bionexus, Inc.
5257 N. Blvd.
P.O. Drawer 58517
Raleigh,  NC  27658
Correspondent Contact CHARLES R DESMET
Regulation Number884.1300
Classification Product Code
HES  
Date Received10/25/1984
Decision Date 08/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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